The regulatory system for medical devices is quite different from that for
pharmaceuticals and may catch many people unawares. For instance, it does n
ot involve the grant of a marketing authorization by a medicines agency. In
stead, a 'declaration of conformity' is made by the manufacturer, but in ma
ny instances this is subject to approval by an independent certification ho
use (known as a notified body).
The Medical Devices Directive 93/42/EEC is applied in each EEA State by nat
ional Legislation. In the UK, for example, the relevant law is the Medical
Devices Regulations 1994, and responsibility for enforcement rests with the
Medical Devices Agency. Non-compliance with the regulations can incur a cr
iminal penalty. (C) 1999 The Hospital Infection Society.